Miravo Healthcare™ Announces the Canadian Commercial Launch of Blexten® for Patients 4 Years of Age and Older*

Rhea-AI Summary

Nuvo Pharmaceuticals (TSX:MRV; OTCQX:MRVFF) has launched Blexten, a new antihistamine for pediatric patients aged 4 and older, in two formats: a 2.5mg/mL oral solution and a 10mg rapidly dispersing tablet. This was announced following Health Canada's approval in August 2021. The new formulations aim to provide effective relief for seasonal allergic rhinitis and chronic spontaneous urticaria. Blexten is derived from bilastine, which is approved in over 121 countries. The company's strategic intent is to expand its pediatric offerings and strengthen its market presence.

Positive

• Launch of Blexten in two new pediatric formats enhances product offerings.
• Approval by Health Canada positions the product well for market entry.
• Strategic expansion into pediatric healthcare market could drive sales growth.

Negative

• None.

- For the Treatment of the Symptoms of Seasonal Allergic Rhinitis and Chronic Spontaneous Urticaria (such as itchiness and hives) -

- 2.5mg/mL Oral Solution and (rapidly dispersing)10mg Orodispersible (Quick Melt) Tablet Formats -

MISSISSAUGA, Ontario--(BUSINESS WIRE)-- Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian-focused healthcare company with global reach and a diversified portfolio of commercial products, today announced that its wholly owned subsidiary, Aralez Pharmaceuticals Canada Inc. has launched Blexten for pediatric use in patients 4 years of age and older*.

“Our sales force is excited to present our new Blexten formulations to the healthcare community. Blexten pediatric was approved by Health Canada in mid August 2021. The recent Canadian launch of the two new formats of Blexten, 10mg tablet and 2.5mg/mL oral solution for pediatric use, in addition to our existing 20mg tablet format available for patients 12 years of age and older, provides a single prescription antihistamine option for most Canadian allergy and urticaria patients,” said Jesse Ledger, Miravo’s President & Chief Executive Officer.

"The introduction of Blexten pediatric with two new formats, orodispersible tablet (quick melt) and oral solution, gives us new prescription antihistamine options for allergy symptom control in children.”

Timothy Vander Leek, MD, FRCPC
Allergist & Clinical Immunologist
Department of Pediatrics at the Stollery Children’s Hospital, University of Alberta

“A new prescription strength antihistamine for children 4 years of age and over* is a welcome addition to our treatment options for the hives and itching of chronic spontaneous urticaria.”

Jaggi Rao, MD, FRCPC (Dermatology)
Dermatologist and Clinical Professor, University of Alberta

About Blexten
Blexten is a second-generation antihistamine drug for the symptomatic relief of allergic rhinitis and chronic spontaneous urticaria. Blexten exerts its effect through its highly selective inhibition of peripheral histamine H1 receptors and has an efficacy comparable to cetirizine and desloratadine. In comparative studies, Blexten demonstrated somnolence rates similar to placebo representing a potentially non-sedating effect at therapeutic doses. It was developed in Spain by Faes Farma, S.A. (Faes). Bilastine, (the active ingredient in Blexten), is approved in Canada and over 121 countries worldwide, including Japan and most European countries. In 2014, Miravo entered into an exclusive license and supply agreement with Faes for the exclusive right to sell bilastine in Canada, which is sold under the brand name Blexten. The exclusive license is inclusive of prescription and non-prescription rights for Blexten, as well as adult and pediatric presentations in Canada.

*Blexten (bilastine ) is indicated for the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and chronic spontaneous urticaria (e.g. pruritus and hives) in patients 4 years of age and older with a body weight of at least 16 kg.

About Miravo Healthcare
Miravo is a Canadian-focused, healthcare company with global reach and a diversified portfolio of commercial products. The Company’s products target several therapeutic areas, including pain, allergy, neurology and dermatology. The Company’s strategy is to in-license and acquire growth-oriented, complementary products for Canadian and international markets. Miravo’s head office is located in Mississauga, Ontario, Canada, the international operations are located in Dublin, Ireland and the Company’s manufacturing facility is located in Varennes, Québec, Canada. The Varennes facility operates in a Good Manufacturing Practices (GMP) environment respecting the U.S., Canada and E.U. GMP regulations and is regularly inspected by Health Canada and the U.S. Food and Drug Administration. For additional information, please visit www.miravohealthcare.com.

Forward-Looking Statements
This press release contains “forward-looking information” as defined under Canadian securities laws (collectively, “forward-looking statements”). The words “plans”, “expects”, “does not expect”, “goals”, “seek”, “strategy”, “future”, “estimates”, “intends”, “anticipates”, “does not anticipate”, “projected”, “believes” or variations of such words and phrases or statements to the effect that certain actions, events or results “may”, “will”, “could”, “would”, “should”, “might”, “likely”, “occur”, “be achieved” or “continue” and similar expressions identify forward-looking statements. In addition, any statements that refer to expectations, intentions, projections or other characterizations of future events or circumstances contain forward-looking statements. These forward-looking statements include statements regarding anticipated product launches, responses to COVID-19, milestone payments, royalties and license approvals.

Forward-looking statements are not historical facts but instead represent management’s expectations, estimates and projections regarding future events or circumstances, including the anticipated receipt of certain milestone and royalty payments, the anticipated launch of certain products and approvals therefor, and the potential impact of COVID-19. Such forward-looking statements are qualified in their entirety by the inherent risks, uncertainties and changes in circumstances surrounding future expectations which are difficult to predict and many of which are beyond the control of the Company. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable by management of the Company as of the date of this press release, are inherently subject to significant business, economic and competitive uncertainties and contingencies and may prove to be incorrect. Material factors and assumptions used to develop the forward-looking statements, and material risk factors that could cause actual results to differ materially from the forward-looking statements, include but are not limited to, the denial of regulatory approvals, the delay or failure to meet anticipated product launches, the failure to meet certain milestones or collect certain royalties, the potential impact of COVID-19 on the Company’s operations, business and financial results and other factors, many of which are beyond the control of the Company. Additional factors that could cause the Company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the risk factors included in the Company’s most recent Annual Information Form dated March 5, 2021 under the heading “Risks Factors”, and as described from time to time in the reports and disclosure documents filed by the Company with Canadian securities regulatory agencies and commissions. These and other factors should be considered carefully and readers should not place undue reliance on the Company’s forward-looking statements. Forward-looking statements should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not the times at or by which such performance or results will be achieved.

All forward-looking statements are based only on information currently available to the Company and are made as of the date of this press release. Except as expressly required by applicable Canadian securities law, the Company assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements in this press release are qualified by these cautionary statements.

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Investor Relations

Stefan Eftychiou

905 326 1888 ext 60

stefan@bristolir.com

Source: Nuvo Pharmaceuticals Inc.

FAQ

What new products did Miravo Healthcare launch for children?

Miravo Healthcare launched Blexten in two new formats: a 2.5mg/mL oral solution and a 10mg rapidly dispersing 10mg tablet for pediatric use.

When was Blexten approved by Health Canada?

Blexten was approved by Health Canada in mid-August 2021.

What age group is Blexten indicated for?

Blexten is indicated for children aged 4 years and older with a body weight of at least 16 kg.

What conditions does Blexten treat?

Blexten is used for the symptomatic relief of seasonal allergic rhinitis and chronic spontaneous urticaria, including itchiness and hives.

What is the active ingredient in Blexten?

The active ingredient in Blexten is bilastine.